The document discusses technology transfer in the pharmaceutical industry. It defines technology transfer as the process of transferring manufacturing knowledge from research and development sites to production sites. The key steps in the technology transfer process are developing the technology in R&D, pilot plant studies, transferring technology from R&D to production, optimization and production, documentation, and approval. Successful technology transfer requires effective communication and teamwork between the sending and receiving sites.

1. TECHNOLOGY TRANSFER
Dhadwad Sagar Dashrath
F.Y.M.Pharm
504
Dr.D.Y.Patil IPSR, pimpri
Pharmaceutics Department
Guided by: Dr. Satish Shirolkar

2. Contents
1) Introduction
2) Classification
3) Steps in Technology Transfer Process
4) Contents of Technology Transfer
5) Technology Transfer Team
6) Facets of Technology Transfer
7) Factors Influencing Technology Transfer
8) Cases/Examples of technology transfer
9) Success of technology Transfer
10) CONCLUSION

3. 1. Introduction
 According to WHO, Technology Transfer is a logical procedure that
controls the transfer of any process together with its documentation
and professional expertise between manufacture sites.
 Technology transfer is defined as the transfer of manufacturing
process for a new pharmaceutical drug substance and drug product
respectively, from the transferring site (in these case R&D) to receiving
site or designated manufacturing site.
 It also refers to the processes of successful progress from drug
discovery to product development, clinical trials and ultimately full
scale commercialization.

4. • It is both integral and critical to drug discovery &development process
for new medicinal products.
• It is helpful to develop dosage forms in various ways as it provides
efficiency in process,maintains quality of product , helps to achieve
standardized process which facilitates cost effective production.
• Technology transfer is important for such research to materialize on a
larger scale for commercialization especially in the case of developing
product. Technology transfer includes not only patentable aspects of
production but also includes the business processes such as knowledge
and skills.

5. 1.1 Goal of technology transfer
 It is to transfer product and process knowledge between and
manufacturing and within or between manufacturing sites to achieve
product realization. This knowledge forms the basis for the manufacturing
process, control strategy process validation approach and ongoing
continual improvement.
1.2 Objective of technology transfer
 To explain the processing information to transfer technology from R&D to
production site by listing out information gathered during R&D.
 To explain the processing information to transfer technology of already
existing drug product between various places.

6. 2. Classification
i. Vertical technology transfer : It refers to the transfer of data from
basic study to development and production respectively.
ii. Horizontal technology transfer : It refers to the movement and
application of technology is to be used in one place or context to a
different place

7. Technology developer (R&D Lab)
Technology receiving site (process development lab)
Feasibility study
Scale-up
Exhibit batches
Stability study
Process validation batches
Production batches(Commercialization)
• Flowchart of Technology transfer in pharmaceutical industry

8. 3. Steps in Technology Transfer Process
A. Development of technology by R&D [Research Phase]
B. Pilot plant
C. Technology transfer from R&D to production [Development Phase]
D. Optimization and Production (Production Phase)
E. Procedures and documentation of technology transfer
F. F. Check & Approval

9. A. Development of technology by R&D
[Research Phase]
a) Design of procedure and selection of excipients by R&D.
b) Identification of specification and quality by R&D.

10. B. Pilot plant
 Pilot plant: Lab scale formula is transformed into a viable product by
development of reliable practical method of manufacture.
 Scale-up: the art of designing of prototype using the data obtained from
the pilot plant model.
 The pilot plant plays a critical role in the technology evaluation, scale up
and transfer activities of new products a properly designed and
operated pilot plant can aid in the enhanced collection of scientific data
necessary for the support of internal transfer activities as well as
regulatory submissions.
R&D Pilot scale Scale up
Large scale
production

11. B. Pilot plant
Key technical aspects that must be addressed during scale-up in the pilot
plant includes:
i. Identification and control of critical component and formulation
variables early in development
ii. Pilot plant equipment simulates as closely as possible to the equipment
that will be used at the manufacturing site
iii. Identification of critical process parameters and operating ranges for
the pilot plant equipment through the use of statistically designed
experiments
iv. Collection of product and process data to adequately characterize each
unit operation.

12. C . Technology transfer from R&D to
production [Development Phase]
a) Master Formula Card (MFC).
b) The generic name, MFC number, page number, effective date, shelf life,
and market.
c) Master Packaging Card.
d) Master Formula.
e) Specifications and Standard Test Procedures (STPs).

13. D . Optimization and Production
(Production Phase)
a) Validation Studies
b) Scale Up for Production

14. E . Procedures and documentation of
technology transfer
a) Research and development report
b) Technology transfer documentation
c) Product Specification file
d) Technology transfer plan
e) Technology transfer report
f) Check and approval by Quality Assurance Department
g) For implementation of technology transfer
h) Manufacturing related documents including drug product standard
i) Verification of results of technology transfer
j) Points of concerns for post-marketing technology transfer

15. F. Check & Approval
1. Production master formula
2. Manufacturing instruction
3. Dispensing instruction
4. Analytical methods
5. Previous process validation
6. Stability report
7. Excipients specification &
source
8. Active specification & source
9. Primary packaging material
specification & source
10. Packaging instruction
11. Customer complaints
12. Process deviation file
13. Analytical deviation file
14. Reject/Rework file
15. Specimen manufacturing batch record
16. Specimen cartons, labels

16. 4. Contents of Technology Transfer
Proper
Research
Proper
work
pricing
publicit
y
partnershi
p
People’s
acceptanc
e
6P

17. 5.Technology transfer team
a) Process technologist
 Central focus for transfer activity
 Collates documentation from donor site
 Perform initial assessment
b) QA representative
 Review documentation to workout compliance wit market
authorization
 Review analytical strategies with QC
 Initiates &confirms regulatory needs

18. c) Production representative
Review process instruction
Considers any safety implication
Considers training requirement
d) Engineering representative
• Review production instrumentation requirement
• suggest requirement engineering modification
• Review preventive, maintain & calibration impact
e) QC representative
• Review analytical requirement
• Availability with instrument
• Responsible for analytical technique transfer for drug substance
and drug product

19. 6. Facets of Technology Transfer
 Government labs to the private sector
 Between the private sector firms of the same country
 From academia to private sector firms
 Academia, government and industry collaborations

20. 7.Factors Influencing Technology Transfer
a) Drivers for Technology Transfer
b) Barriers of Technology Transfer
c) Approaches to overcome barriers in technology transfer

21. a) Drivers for Technology Transfer
 Good business and manufacturing practices
 Potential for competitive pricing
 Strategic planning
 Promising market scale and accessibility
 Adherence to regulatory standards
 Skilled workforce
 Innovation- friendly environment with sound Intellectual Property Protection and
Enforcement
 Proper access to information or increased information exchange

22. a) Drivers for Technology Transfer
 Opportunities for contingency supply
 Access to new machinery, training, know-how and business partnership

23. b) Barriers of Technology Transfer
 Lack of awareness knowledge and efficiency
 Lack of government focus low market share
 Web access and scientific publication
 Cost of prequalification
 National security issues and restrictions on exports of particular
technology
 Inadequate funding in important areas and possible treaties
 Labour issues

24. c) Approaches to overcome barriers in
technology transfer
 Commercializing publicly funded technologies
 Political stability and good transparent governance
 Research tool patents and freedom to operate for the public sector
 Appropriate Capital Markets
 Co-operative research agreements

25. 8. Cases/Examples of technology
transfer
 The Bhabha Atomic Research Centre (BARC)
 The National Chemical Laboratory (NCL) Pune
 Department of Biotech (DBT)
 Eli Lilly and company: has a technology transfer agreement with
Shasun Chemicals and Drugs for the manufacturing of anti T.B drug
CYCLOSERINE produced by Shasun to meet Eli Lily global demand.
 Center of disease control and prevention(CDC)- New Live Attenuated
Vaccine Against All Four Types Of Dengue Infection.

26. 9. Success of technology Transfer
 The Communication: Open communication between all team members.
 The Direct communication between technical members.
 The effective and timely communication with regulators.

27. Team work, most of the time……..
Sending and Receiving Unit “ Technology transfer is not a one way street”.
The sending & receiving unit must be equally involved in the process to
ensure success.
The Team work at all time.

28. 10. CONCLUSION
 The transfer involves cost and expenditure that is negotiated and agreed upon
by the transferee and transferor. The transfer may be said to be successful if
the transferee can successfully utilize the technology for business gains and
eventually assimilate it.
 Appropriate efficiency in technology transfer from development to
commercialization can be achieved through better communication and
documentation by technology transfer team.
 Use of enriched approaches like technology transfer to the development and
start-up of new production systems will enable pharmaceutical organizations to
fully benefit from the recent improvements in the new drug discovery and to
complete more effectively in a rapidly changing marketplace.

29. REFERENCES
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TECHNOLOGY TRANSFER IN PHARMACEUTICAL INDUSTRY-A REVIEW,
World Journal of Pharmaceutical Research; Volume 6, Issue 9, 310-329 2017.
 Swapnil Nivrutti Misar, Akshaykumar Vinodrao Bhurghate, Jitendra Singh
Sisodia, Somnath Kailas Gaikwad and Hitendra Brijlal Patil:Technology
Transfer: A Paradigm for Industry. Int. J. Pure App. Biosci. 2 (2): 221-228
(2014).
 Popat B. Mohite* and Sachin V. Sangle:Technology transfer in pharmaceutical
industry- A Review. International Journal of Advances in Pharmaceutics 2017;
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 http://www.slideshare.net/polurikoteswari/pilot-plant-scale-up-techniques-
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